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The MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

The PliaForm™ Breast Tissue Expander w/ Suture Tabs is designed for breast reconstruction, designed for thinner components and a reduction of reinforcement features and minimized insertion profile. The integrated port design consists of a plastic needle guard and a smaller magnetic element to improve MR compatibility (MR Conditional). The next generation design control technology (DCT) facilitates predictable expansion and is shape-optimized to better match the entire implant portfolio. An improved Bufferzone features a new sheeting-based self-sealing technology that offers protection from inadvertent needle punctures across the entire coverage area, and a more flexible design, which improves the overall device flexibility. An internally fixated injection port reduces device bulkiness. The injection port will incorporate a new plastic needle guard with a silicone backing and smaller magnet with reduced magnetic field strength compared to the Artoura™ breast tissue expander devices. This feature reduction improves device compatibility with MR-CT imaging, and external beam radiation (such as photon beam).

Identification of the injection port site is accomplished by use of the CENTERSCOPE™ 2.0 Magnetic Injection Port Locator, which is provided with the Tissue Expander. When the Centerscope™ 2.0 device is placed on top of the skin, the magnetic arm points to the center of the tissue expander's injection port. Injections into the injection port area are made using the provided infusion needle set to inject sterile, pyrogen-free Sodium Chloride U.S.P. Solution.

The MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs incorporates suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability.

The MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs are provided sterile in three styles (Low Height, Medium Height, and Tall Height) and various sizes.

The following accessories are packaged with the MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs:

• Centerscope™ 2.0 Magnetic Injection Port Finder
• Winged Infusion Set (21G)

The provided FDA 510(k) clearance letter is for a physical medical device, the MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs, and not for an AI/software as a medical device (SaMD).

Therefore, the requested information regarding AI/SaMD specific aspects like:

• A table of acceptance criteria and reported device performance for an AI model
• Sample sizes, data provenance, expert ground truth, adjudication methods for training and test sets of an AI model
• Multi-Reader Multi-Case (MRMC) studies or standalone algorithm performance for an AI model
• Type of ground truth and how it was established for training and test sets of an AI model

cannot be extracted from this document.

The document describes acceptance criteria and studies for a physical medical device, focusing on its mechanical properties, biocompatibility, and compatibility with imaging modalities (MR/CT/RT).

Here's the information that can be extracted, tailored to the context of a physical device:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs

This document describes the premarket notification for a physical medical device, the MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs. The acceptance criteria and supporting studies are focused on the device's physical and material performance, safety, and compatibility, rather than the performance of an AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that all mechanical performance testing results met their pre-determined acceptance criteria. While specific numerical acceptance criteria (e.g., minimum bond strength in Newtons) are not explicitly detailed in the summary, the categories of tests and the conclusion that they were met serve as the reported performance against the criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for each mechanical, biocompatibility, or MR/CT/RT test. For a physical device, testing is typically done on a defined number of manufactured units to demonstrate design validation and manufacturing quality. The data provenance is derived from these laboratory tests, not from patient data, and is prospective based on manufacturing and testing protocols. No specific country of origin for test data is mentioned, as is common for laboratory-based performance testing of medical devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This question is not applicable in the context of this device. "Ground truth" for a physical device is established through engineering specifications, material science principles, and adherence to industry standards (e.g., ASTM F1441-03 for soft-tissue expanders). The "experts" involved would be engineers, material scientists, and quality assurance personnel responsible for designing, manufacturing, and testing the device against these objective criteria.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or AI evaluations to resolve discrepancies in human interpretations or expert annotations. For physical device testing, results are typically quantitative and objectively measured against pre-defined engineering thresholds. Deviations from these thresholds would be considered failures, not subject to subjective adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. MRMC studies are used to assess the diagnostic performance of human readers, often comparing performance with and without AI assistance. This document pertains to a physical implantable device, not a diagnostic AI system or an imaging modality.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance

Not applicable. This device is not an algorithm or AI system. Its "performance" is inherent to its physical properties and function when implanted.

7. The Type of Ground Truth Used

The "ground truth" for this physical device is defined by:

• Engineering Specifications: Design parameters, material properties, and functional requirements established during product development.
• Industry Standards: Compliance with recognized standards such as ASTM F1441-03 for soft-tissue expanders.
• Biocompatibility Standards: Adherence to ISO 10993 series for medical device biocompatibility.
  All test methods measure against these predefined, objective criteria.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI model requiring a training set. Its design and manufacturing processes are developed through engineering R&D, not machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As this is not an AI model, there is no "ground truth for a training set." The design and manufacturing are based on established engineering principles, material science, and regulatory requirements.

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The MENTOR™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander with fill volume to 1445cc can be used for breast reconstruction after mastection of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.

The MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander is used for breast reconstruction following mastectomy and is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months. The proposed device consists of a smooth surface shell made with successive cross-linked layers of silicone elastomer identical to the predicate device (K241918). Again, identical to the predicate device, the subject device contains superior and anterior reinforcement which allows for directional expansion in the lower pole of the device has an integral, silicone elastomer, magnetically detected, injection dome and incorporates a BUFFERZONE™ area with self-sealing technology (containing silicone gel) to the front patch of the device to minimize and/or prevent leakage in the event of an accidental needle puncture. The CPX™4 PLUS Enhance Breast Tissue Expander Injection Dome houses a rare-earth, permanent magnet. This internal magnet, when in conjunction with the CENTERSCOPE™ Magnetic Injection Port Locator accessory, helps the injector accurately identify the injection dome during patient tissue expander fill procedures.

This FDA 510(k) premarket notification is for the Mentor™ CPX™4 PLUS Enhance Breast Tissue Expander, which is a medical device for breast reconstruction. The submission is specifically to expand the lower limit fill volume of the device from 930cc to 850cc, aligning it with a predicate device (K152496).

Based on the provided text, here's a description of the acceptance criteria and the study that demonstrates the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

No new test set was used for this 510(k) submission. The submission relies on the established performance of the predicate device (K241918) and the equivalence of the materials and design. The change is solely to expand the lower limit of the fill volume range.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable, as no new clinical or performance test set was described for this specific submission. The submission leverages the prior clearance of predicate devices, which would have undergone their own testing and validation processes.

4. Adjudication Method for the Test Set:

Not applicable, as no new test set requiring expert adjudication was described for this specific submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This device is a breast tissue expander, not a diagnostic imaging AI algorithm that would typically be evaluated with MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable, as this is a physical medical device (breast tissue expander), not an algorithm or AI software.

7. The Type of Ground Truth Used:

For the original predicate device clearances on which this submission relies, the ground truth for mechanical performance would have been established through objective measurement of physical properties and performance benchmarks (e.g., pressure testing, leak testing) according to ASTM standards. Biocompatibility ground truth would be established through established biological evaluation tests based on ISO 10993.

8. The Sample Size for the Training Set:

Not applicable, as this is a physical medical device, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as this is a physical medical device, not an AI algorithm requiring a training set.

Summary of the Study Proving the Device Meets Acceptance Criteria for this specific 510(k):

The submission for the Mentor™ CPX™4 PLUS Enhance Breast Tissue Expander with fill volumes from 850cc to 1445cc does not describe new studies or new acceptance criteria. Instead, it presents a special 510(k) where the core argument for meeting acceptance criteria is that:

1. Identical Technology and Materials: The proposed device has the same scientific technology, principles of operation, intended use, indications for use, and all patient contact materials as the cleared predicate device (K241918).
2. Worst-Case Mechanical Testing Already Performed: Previous mechanical testing on the predicate device (K241918) was conducted at the maximum labeled fill volume of 1445cc. This volume represents the "worst case" for overexpansion and bladder leak testing, as it results in the most internal pressure.
3. No Impact of Lower Fill Volume: Reducing the lower limit fill volume from 930cc to 850cc does not adversely affect the mechanical performance (overexpansion and bladder leak) already demonstrated at the worst-case 1445cc. Therefore, no new mechanical testing was deemed necessary.
4. Established Biocompatibility: Since all patient contact materials are identical to the predicate device, which has already established biocompatibility, no new biocompatibility testing was required for this submission.

In essence, the "study" proving the device meets acceptance criteria for this particular submission is the analysis of device equivalence and the justification that prior testing on the predicate device at its most challenging parameters (highest fill volume) sufficiently covers the slightly expanded range offered by the subject device (lower fill volume).

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The Mentor™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander with fill volume to 1445cc can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.

The MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander is used for breast reconstruction following mastectomy and is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months. The proposed device consists of a smooth surface shell made with successive cross-linked layers of silicone elastomer. Superior and anterior reinforcement allows for directional expansion in the lower pole of the device has an integral, silicone elastomer, magnetically detected, injection dome and incorporates a BUFFERZONE™ area with selfsealing technology (containing silicone gel) to the front patch of the device to minimize and/or prevent leakage in the event of an accidental needle puncture. The CPX™4 PLUS Enhance Breast Tissue Expander Injection Dome houses a rare-earth, permanent magnet, This internal magnet, when in conjunction with the CENTERSCOPE™ Magnetic Injection Port Locator accessory, helps the injector accurately identify the injection dome during patient tissue expander fill procedures.

Identification of the injection dome site can be accomplished by use of the CENTERSCOPE™ Magnetic Injection Port Locator provided with the Tissue Expander. Instructions for use of the CENTERSCOPE™ Magnetic Injection Port Locator are provided within this document. Injections must be made using sterile, pyrogen-free Sodium Chloride U.S.P. Solution and into the injection dome area. If injections are made on or outside the injection dome, leakage can occur.

The MENTOR™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander gives surgeons the option to attach the device to surrounding tissue to enhance device stability. Surgeons can suture on any part of the tab surface or the suturing hole can be used for added convenience.

The MENTOR™ CPX™4 PLUS Enhance Smooth Breast Tissue Expander, Catalogue Number SCPX-15TH-E, provides fill volume options from 930 cc to 1445 cc.

The following accessories are packaged with the CPX™4 PLUS Enhance Breast Tissue Expander:

• Centerscope Magnetic Injection Port Finder .
• Winged Infusion Set .

The provided text describes the 510(k) premarket notification for the MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's clinical performance. As such, information regarding acceptance criteria for AI/algorithm performance, sample sizes for test and training sets, expert qualifications, or multi-reader multi-case studies is not applicable to this document.

The document primarily outlines the device's technical specifications, indications for use, and a comparison to predicate devices, supported by biocompatibility and mechanical testing.

Here's a breakdown of the information that is available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/Algorithm Related)

The document mentions acceptance criteria related to mechanical testing, but the specific numerical criteria are not detailed. It only states that the results met the pre-determined acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is not a study involving a "test set" of data in the context of an AI/algorithm. The device underwent physical and material testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This is not a study involving expert-established ground truth for an AI/algorithm.

4. Adjudication Method

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size

No, an MRMC comparative effectiveness study was not done. This device is a breast tissue expander, not an AI/algorithm.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Not applicable.

8. The Sample Size for the Training Set

Not applicable.

9. How the Ground Truth for the Training Set was Established

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (Based on the Provided Text):

The device (MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander) demonstrates that it meets acceptance criteria through:

• Biocompatibility Testing: The device utilizes materials identical to a previously cleared predicate device for permanent tissue contact. This indicates that the materials have already met biocompatibility standards and no new testing was required.
• Mechanical Testing: Specific mechanical tests were conducted in accordance with ASTM F1441-03, "Standard Specification for Soft-Tissue Expanders." These tests evaluated parameters such as overexpansion and bladder leak. The document states that all results met pre-determined acceptance criteria, thus demonstrating substantial equivalence to the predicate device. The changes specifically addressed in this testing were the change to a smooth surface and the addition of three suture tabs, which impacted the connection of external components (Base and Injection Dome) to the shell surface.

The "study" described is primarily a series of engineering and materials tests demonstrating that the modified physical device (with a smooth surface and additional suture tabs) maintains the same safety and performance characteristics as its predicate devices, especially regarding its physical integrity and material compatibility.

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For temporary (less than six months) subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts and to aid treatment of soft tissue deformities.

The Motiva Flora® SmoothSilk® Tissue Expander (MFSTE) is intended for temporary subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage and is not intended for use beyond six (6) months. All MFSTEs require periodic, incremental inflation with sterile saline for injection until the desired tissue expansion is developed. Once the desired tissue expansion is achieved, the tissue expander is surgically removed and a breast implant is inserted within the breast pocket.

The MFSTE is constructed of successive cross- linked layers of silicone elastomer with an Integrated Injection Port system for incremental expander filling. The Tissue Expanders are available in a range of sizes to meet diverse patient needs and achieve individualized aesthetic results. The MFSTE has a controlled surface architecture produced by the mandrel imprinting technique with an average roughness of 4 microns. Each MFSTE is supplied sterile.

The injection port is dome-shaped with a radiofrequency identification (RFID) coil embedded in the needle stop. This needle stop prevents inadvertent puncture through the base of the injection port during the filling process.

The injection port is found with the Motiva Flora® Port Locator accessory through the air wound coil's RFID signal placed inside the needle stop. The RFID wireless system comprises two components: the tag and the reader. The Motiva Flora® Port Locator (the reader) has antennas that emit radio waves and receive the signal coming from the RFID coil tag in the needle stop to locate the center of the injection port. The user interface of the Motiva Flora® Port Locator includes LED lights to guide the user during the process. This is an innovative technology not available in other tissue expanders on the market.

In addition, the RFID transponder functions as a traceability feature, which provides a unique electronic serial number (ESN) for each expander. The ESN allows access to a database with the device information (serial and lot number, size, projection, model, manufacturing date, etc.).

Additional design features of the MFSTE include a non-ferromagnetic component design that allows the device to be used with Magnetic Resonance (MR) and Computerized Tomography (CT) under certain conditions.

The MFSTE includes six (6) fixation tabs (TrueFixation®) to provide the surgeon options to suture the tissue expander in the breast pocket. Another design feature is its reinforced base.

The provided text describes a medical device, the Motiva Flora® SmoothSilk® Tissue Expander, and the studies conducted to demonstrate its substantial equivalence to a predicate device for FDA 510(k) clearance.

However, the information provided does not pertain to an AI/ML-enabled medical device. The document describes tests related to:

• Biocompatibility: Testing to ensure the materials are safe for use in the human body.
• Animal Testing: To compare tissue reaction to the device and a predicate.
• Mechanical Testing: To evaluate physical properties like elongation, tensile strength, and injection port integrity.
• Sterilization Testing: To confirm the device can be properly sterilized.
• Port Locator Electrical Safety & EMC Testing: For the accessory device that helps locate the injection port (this is not an AI/ML component; it relies on RFID and basic electrical/electromagnetic principles).
• Port Locator Software Testing: Standard software validation, not specifically AI/ML performance.
• MR Conditional Testing: To ensure compatibility with MRI environments.

Therefore, many of the specific questions about AI/ML device acceptance criteria and study design (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, effect size) are not applicable to this document. The document focuses on demonstrating physical, chemical, and biological equivalence, along with the safety and basic functionality of the device and its non-AI accessory.

To answer your request based on the provided text, I can only address aspects relevant to a non-AI medical device.

Since the provided document does not describe an AI/ML-enabled medical device, many of the requested categories related to AI/ML specific studies (e.g., sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone performance) are not applicable.

However, I can extract the general acceptance criteria and the performance studies conducted for this non-AI medical device.

1. A table of acceptance criteria and the reported device performance:

The document describes "pre-determined acceptance criteria" for various tests, and states that "All testing met the requirements" or "All testing results met their pre-determined acceptance criteria," or "demonstrate[d] that the MFSTE is substantially equivalent." Specific numerical acceptance thresholds are not explicitly listed in the summary, but the types of criteria are implied by the tests performed.

2. Sample sizes used for the test set and the data provenance:

• Sample Size: Not specified in the provided summary for any of the tests (e.g., number of devices tested for mechanical properties, number of animals in the GLP study).
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: Unclear from the summary. Animal studies are typically prospective. Mechanical, sterilization, and electrical/EMC tests are conducted under controlled, often laboratory, conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable for a non-AI physical device validation. "Ground truth" in this context refers to established standards (e.g., ASTM standards for mechanical properties, ISO standards for biocompatibility) or direct measurements. For the animal study, histopathologic evaluation would be performed by qualified pathologists, but the number of experts is not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable for a non-AI physical device validation. Adjudication methods are typically for subjective assessments, like image interpretation in AI studies. The tests described are objective (e.g., measurement of tensile strength, electrical output, presence/absence of foreign body reaction by pathologists).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is a physical tissue expander; it does not involve human readers interpreting images, nor does it have an AI component to assist them.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a physical device, not an algorithm. The "Port Locator" is an accessory device that functions using RFID, not an AI algorithm.

7. The type of ground truth used:

• For Mechanical, Sterilization, Electrical/EMC, and MR Conditional Testing: Ground truth is defined by established engineering and medical device standards (e.g., ASTM, ISO, IEC, FCC) which specify acceptable performance ranges and test methodologies.
• For Biocompatibility: Ground truth is established by ISO 10993 standards and FDA guidance, relying on recognized biological reactions and toxicology principles.
• For Animal Testing: Ground truth is based on histopathological evaluation by qualified experts (pathologists) determining typical vs. adverse tissue responses.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable. As above, no training set for an AI algorithm is involved.

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The Sientra AlloX2 Pro Tissue Expanders are intended for temporary (less than six months) subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstructions following mastectomy, to aid in the treatment of underdeveloped breasts and to aid in treatment of soft tissue deformities.

Additionally, the Sientra AlloX2 Pro Tissue Expanders contain a silicone drain component which allows access to and drainage of latent fluids from the periprosthetic space. This drain component does not teplace short-term, immediate, intraoperatively placed drains.

The Sientra AlloX2 Pro Tissue Expanders are constructed from silicone elastomer and consist of an expansion envelope with a smooth surface and an integrated magnetically locatable port system for incremental expander filling. The Sientra AlloX2 Pro Tissue Expanders have an incorporated drainage system accessed by a drain port. The incorporated drain system allows for aspiration of fluids from the periprosthetic space that may present during the expansion process. Both the integrated fill and drain ports can be accessed with an 18- gauge needle or smaller. The AlloX2 Pro Tissue Expanders have suture tabs providing an option for surgeons to suture the expander within the breast pocket. The AlloX2 Pro Tissue Expanders are labeled Magnetic Resonance (MR) Conditional. Patients implanted with the AlloX2 Pro Tissue Expanders may undergo Magnetic Resonance Imaging under specific MR conditions. The potential resulting risks associated with using the device in the MRI environment include the inability to fill the device, loss of port location functionality and potential reoperation should the patient require continued function of the tissue expander device after MRI exposure.

The Sientra AlloX2 Pro Tissue Expanders are manufactured in both mid-height and fullheight base options from 11 cm to 16 cm to meet diverse patient needs and to achieve individualized aesthetic results. The Sientra AlloX2 Pro Tissue Expanders are supplied sterile. The Sientra AlloX2 Pro Tissue Expander accessories include a magnetic port locating device (PRO Locator) that allows for simultaneous identification of the fill and drain ports for ease of identification, and a 21-gauge winged needle infusion set. Both are supplied sterile and individually packaged inside the product box.

This document describes the premarket notification (510(k)) for the Sientra AlloX2 Pro Tissue Expanders. The device is a silicone elastomer tissue expander with an integrated magnetically locatable port system and a drainage system. The submission aims to demonstrate substantial equivalence to the predicate device, the Sientra AlloX2 Tissue Expander (K140383).

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state specific sample sizes for each test in terms of individual devices or units. It broadly refers to "All necessary performance testing" and implies that a sufficient number of samples were used to meet the requirements of the standards (e.g., ASTM, ISO).

• Data Provenance: The studies were non-clinical bench testing. The country of origin for the data is not specified, but it can be inferred that the testing was conducted by or on behalf of Sientra, Inc., a US-based company. The data is retrospective in the sense that it was generated prior to the 510(k) submission to demonstrate equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There were no human experts used to establish a "ground truth" for the performance testing in the traditional sense of clinical assessment. This device's evaluation relies on objective engineering and material science standards. The ground truth for these tests is defined by the technical specifications and acceptance criteria outlined in the relevant ASTM and ISO standards.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical bench testing study relying on objective measurements against established engineering and material standards, not subjective assessments requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "Clinical data is not necessary to establish the substantial equivalence of this device." This implies no human reader studies were conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, from a performance perspective, the "standalone" performance of the device (without human interaction for evaluation purposes) was assessed through the various bench tests. The device itself does not involve an algorithm or AI. All performance testing described (sterilization, shelf-life, biocompatibility, mechanical, MR safety) is of the device's inherent properties and function, without direct human influence on the results of the test beyond setting up the experiment.

7. The Type of Ground Truth Used

The ground truths used for the performance testing were:

• Standard Specifications and Industry Norms: For mechanical testing, this was ASTM F1441-03. For MR safety, this was ASTM F2503-20 and FDA Guidance.
• Regulatory Requirements: For biocompatibility, this was ISO 10993-1. For sterilization, this was achieving a Sterility Assurance Level (SAL) of -6.
• Predicate Device Equivalence: The ultimate ground truth for this submission is demonstrating that the new device performs equivalently to the legally marketed predicate device (Sientra AlloX2 Tissue Expander, K140383) in terms of safety and effectiveness, based on these objective tests.

8. The Sample Size for the Training Set

Not applicable. This device is a medical implant, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

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The Sientra Portfinder is a battery-operated standalone port detection device that is intended for use with the Sientra AlloX2 Pro and Dermaspan Tissue Expanders.

The Portfinder is an electronic handheld injection port detector device that externally locates subcutaneous ports of an implanted tissue expander, enabling fill of the tissue expander or use of the drain system.

The enclosed device is nonsterile and for postoperative use only.

The Portfinder is an electronic handheld injection port detector device that externally locates subcutaneous ports of an implanted tissue expander. The Portfinder is intended to locate the fill and drain ports of the Sientra AlloX2 Pro Breast Tissue Expanders (AlloX2 Pro) and fill port of the Sientra OPUS Dermaspan Breast Tissue Expanders (Dermaspan); enabling the user to mark the location of the ports for subsequent fill and drain of the respective tissue expander.

The Portfinder contains an LCD screen that displays the location of the intended port (drain or fill port). A single button of the Portfinder is used to power on/off and change modes.

The Portfinder housing has features to temporarily indent the port location on the surface of the skin or use a skin marker to mark the port location.

The Portfinder is intended to be used by clinicians in medical settings such as hospitals and medical clinics. It can be disinfected between uses for multi-patient reuse.

The provided document does not contain detailed information about the acceptance criteria or a specific study proving the device meets those acceptance criteria. However, it does mention "Design verification tests were performed on the Portfinder as a result of the risk analysis and product requirements" and "Software Verification and Validation testing was performed on Portfinder".

Without the full details of these verification and validation tests, it's not possible to populate all the requested fields comprehensively. The document explicitly states that clinical testing was not necessary to demonstrate substantial equivalence, which means the study described would likely be bench testing.

Based on the available information, here is a summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample size: Not specified. The document only mentions "Design verification tests" and "Software Verification and Validation testing."
• Data provenance: Not specified. These would be laboratory-based verification and validation data, likely from internal testing at Sientra, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided. Since clinical testing was not performed, "experts" in the context of establishing clinical ground truth (e.g., radiologists) would not be applicable here. Ground truth would likely be based on engineering specifications and direct measurement/observation in a lab setting.

4. Adjudication method for the test set

• Not specified. Given the nature of bench and software testing, a formal adjudication process like 2+1 or 3+1 would not typically be used. Testing would likely involve comparing device output against known inputs or expected behaviors.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. The document explicitly states, "Clinical testing was not necessary to demonstrate substantial equivalence of Portfinder to the predicate device." The device is a port detector, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Yes, a form of standalone performance was assessed. The "Software Verification and Validation testing" and "Design verification tests" would evaluate the device's performance independently, without human interaction in a clinical setting, to ensure it met its operational requirements. The device itself is described as a "standalone port detection device."

7. The type of ground truth used

• Engineering specifications and known physical properties/measurements. For functional testing, ground truth would be established by the known location of the tissue expander ports in test setups. For software testing, the ground truth would be defined by the expected behavior and outputs based on software requirements.

8. The sample size for the training set

• Not applicable as this is not an AI/machine learning device that requires a training set in the conventional sense. The software mentioned is likely embedded control software, not a learning algorithm.

9. How the ground truth for the training set was established

• Not applicable (see point 8).

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The Natrelle® 133 Plus MICROCELL™ Tissue Expander can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision, and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

Natrelle® 133 Plus MICROCELL™ Tissue Expanders are designed to develop tissue flaps as part of 2-stage reconstruction mammoplasty. The devices are constructed from silicone elastomer and consist of an expansion envelope with a MICROCELL™ textured surface, an orientation line, three suture tabs, a MAGNA-SITE® integrated injection site, and a stable base to enable outward expansion. The tissue expanders are available in multiple styles and sizes to meet diverse surgical needs.

The MAGNA-SITE® injection site and MAGNA-FINDER® Xact external locating device contain rare-earth, permanent magnets for an accurate injection system. When the MAGNA-FINDER® Xact external locating device is passed over the surface of the tissue being expander, its rare-earth, permanent magnet indicates the location of the MAGNA-SITE® injection site. The injection site is self-sealing and includes a titanium needle guard to prevent inadvertent puncture through the base of the injection site.

The provided text is a 510(k) summary for the Natrelle® 133 Plus MICROCELL™ Tissue Expander. It describes the device, its intended use, and its technological characteristics. However, it does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI-powered diagnostic or assistive tool.

The "Performance Data" section states:

"Non-clinical performance data, including mechanical testing data and biocompatibility data, were submitted to support clearance of Natrelle® 133 Plus MICROCELL™ Tissue Expanders. Where appropriate, testing was conducted according to methods prescribed by relevant ASTM and/or ISO standards. All pre-established acceptance criteria were met."

This refers to physical device performance, mechanical properties, and biocompatibility, not the performance of an AI system, human-in-the-loop performance, or the use of ground truth established by experts.

Therefore, I cannot fulfill your request for the specific details outlined (AI performance metrics, sample sizes for AI training/test sets, expert adjudication methods, MRMC studies, standalone performance, or ground truth establishment for AI) because this information is not present in the provided document. The document pertains to a medical device (tissue expander), not an AI system.

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The CPX 14 Breast Tissue Expanders with Smooth Surface can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

The CPX™4 Tissue Expanders with Smooth Surface consist of a silicone elastomer shell, with superior and anterior reinforcement that allows for directional expansion in the lower pole of the device. The device has an integral, silicone elastomer, magnetically detectable injection port. The injection port also incorporates a BUFFERZONE® area with self-sealing technology which is attached to the inside of the anterior surface of the device. The BUFFERZONE® is intended to minimize and/or prevent leakage in the event of an accidental needle puncture. Identification of the injection port site is accomplished by use of the CENTERSCOPE® Magnetic Injection Port Locator, which is provided with the Tissue Expander. When the Centerscope device is placed on top of the skin, the magnetic arm points to the center of the tissue expander's injection dome. Injections into the injection dome area are made using the provided infusion needle set to inject sterile, pyrogen-free Sodium Chloride U.S.P. Solution. The CPX™4 Tissue Expanders with Smooth Surface incorporate suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability. The CPX™4 Tissue Expanders with Smooth Surface are provided sterile. The devices are provided in three styles (Low, Medium and Tall) and in various sizes. The following accessories are packaged with the CPX™4 Tissue Expanders with Smooth Surface: Centerscope Magnetic Injection Port Finder, Winged Infusion Set.

This document is a 510(k) Premarket Notification for a medical device (breast tissue expander). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that an AI device meets specific acceptance criteria. Therefore, most of the requested information regarding AI device performance, sample sizes for training/test sets, expert adjudication, MRMC studies, and ground truth establishment will not be found in this document.

However, I can extract information related to the device's
mechanical testing performance and the acceptance criteria for those tests.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific quantitative acceptance criteria values (e.g., specific force in N, volume thresholds) are not provided in this summary, only that they were "pre-determined" and met.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The document mentions "mechanical testing was conducted on the modified device." It does not specify the number of devices or test repetitions.
• Data Provenance: Not applicable in the context of clinical data for AI. This is a report on mechanical bench testing for a physical device.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

• Not applicable. This relates to mechanical bench testing, not image analysis or clinical diagnosis where expert ground truth would be established. The "ground truth" here is the physical measurement of mechanical properties.

4. Adjudication Method for the Test Set

• Not applicable. This relates to mechanical bench testing. Adjudication methods are typically used for subjective human assessments, e.g., in clinical trials or image labeling.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• No. This document is not about an AI device. It's about a physical medical implant (a breast tissue expander).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done

• No. This is not an AI device.

7. The Type of Ground Truth Used

• Engineering/Physical Measurements: The "ground truth" for this device's performance is derived from standardized mechanical testing (specifically, ASTM F1441-03 for soft-tissue expanders) and risk analysis procedures. The results are objective measurements of physical properties (joint strength, overexpansion).

8. The Sample Size for the Training Set

• Not applicable. This is not an AI device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

• Not applicable. There is no training set as it's not an AI device.

Summary of what the document addresses regarding the device:

The document focuses on demonstrating that the modifications to the CPX™4 Breast Tissue Expander (specifically, a smooth surface instead of textured and increased suture tabs) do not negatively impact its safety and effectiveness compared to the predicate device. This is primarily done through:

• Comparison of Technological Characteristics: Stating that the fundamental technology, principles of operation, intended use, and indications for use remain the same.
• Mechanical Testing: Bench testing was performed to evaluate parameters related to "joint strength and overexpansion" according to ASTM F1441-03. The key finding is that "All mechanical performance testing results met their pre-determined acceptance criteria."
• Biocompatibility Assessment: Confirming that all patient-contact materials are identical to the predicate device, thus new biocompatibility testing was not warranted.

The "acceptance criteria" are implied to be the thresholds or standards outlined in the ASTM F1441-03 standard and Mentor's internal design control procedures for mechanical performance, which the modified device successfully met.

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The Natrelle® 133S Tissue Expander can be used for breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

Natrelle® 133S Plus Tissue Expanders are designed to develop tissue flaps as part of two-stage reconstruction mammoplasty. The devices are constructed from silicone elastomer and consist of a smooth surface expansion envelope, an orientation line, suture tabs, a MAGNA-SITE® integrated injection site, and a stable base to enable outward expansion. The tissue expanders are available in multiple styles and sizes to meet diverse surgical needs.

The MAGNA-SITE® injection site and MAGNA-FINDER® Xact external locating device contain rare-earth, permanent magnets for an accurate injection system. When the MAGNA-FINDER® Xact external locating device is passed over the surface of the tissue being expanded, its rare-earth, permanent magnet indicates the location of the MAGNA-SITE® injection site. The injection site is self-sealing and includes a titanium needle guard to prevent inadvertent puncture through the base of the injection site.

The document describes the Natrelle® 133S Tissue Expander, a medical device, and its substantial equivalence to a predicate device. The information provided heavily focuses on non-clinical performance data and does not involve AI or human reader performance. Therefore, many of the requested points related to AI/human reader studies, ground truth derivation for AI, and specific expert qualifications/adjudication methods are not applicable to this submission.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific quantitative acceptance criteria values (e.g., minimum bond strength, pressure resistance for injection port) are not provided in this summary but are indicated to have been met.

2. Sample Size Used for the Test Set and Data Provenance

The document refers to "mechanical testing data" and "non-clinical performance data." It does not specify a "test set" in the context of patient data or clinical imaging. The testing performed is related to the physical and mechanical properties of the device.

• Sample Size for Test Set: Not specified in terms of number of devices or units tested for each specific mechanical test.
• Data Provenance: The data is from non-clinical performance testing conducted by Allergan or its contractors. No information on country of origin for data is provided as it's not patient-level data. The data is by nature prospective in the sense that the tests were conducted specifically for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This device is a physical tissue expander, and the "ground truth" for its performance is established through objective mechanical and physical testing according to standards like ASTM F1441-03. There's no interpretive clinical data requiring expert consensus or ground truth establishment in the way AI models typically do.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated in point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for AI-assisted image interpretation or diagnostic performance involving human readers. This submission concerns a physical medical implant (tissue expander).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this medical device is based on pre-established objective performance criteria derived from engineering standards (e.g., ASTM F1441-03) and risk analysis, validated through mechanical testing data.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI model for this physical medical device submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the reasons stated in point 8.

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The Unger Quad Injector is intended to be used as the needle infusion set component of a tissue expander fill kit for breast tissue expanders designed to be filled with sterile saline using 21-gauge needles. Specifically, the Unger Quad Injector is indicated for assisting the clinician in delivery of sterile saline into the surgically-placed, sub-dermal, temporary, removable tissue expander.

The Unger Quad Injector is a 'needle infusion set' component to a breast tissue expander fill kit. The device is comprised of four 21 gauge hypodermic lumen needles, which are connected to a needle hub, a luer adapter and tubing.

This document is a 510(k) premarket notification for the Unger Quad Injector, indicating it is a device intended for assisting in the delivery of sterile saline into breast tissue expanders. However, the provided text does not contain acceptance criteria or a study that evaluates the device against specific performance metrics for the purpose of demonstrating clinical accuracy or diagnostic performance, which is typically found in documentation for diagnostic or AI-enabled devices.

Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and non-clinical bench testing. The "acceptance criteria" discussed here are primarily related to conforming to established standards and matching the performance of predicate devices in specific non-clinical tests.

Here's a breakdown of the information that can be extracted or inferred from the provided text, adjusted to the context of this device:

Acceptance Criteria and Device Performance (Non-Clinical Bench Testing)

Since this is a non-AI, non-diagnostic device, the "acceptance criteria" are related to manufacturing standards, material properties, and functional performance compared to predicate devices, rather than accuracy metrics like sensitivity or specificity.

1. A table of acceptance criteria and the reported device performance:
See table above. The "reported device performance" indicates whether the device met the stated standard or showed comparability to the predicate/reference device, as described in the "Non Clinical Tests performed" section and the "Summary of the Technological Characteristics" table.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not detail specific sample sizes for each non-clinical bench test. The studies were non-clinical bench tests, not involving human subjects or real-world data provenance in the sense of patient data. The tests were conducted to verify equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This is not applicable as this device is not an AI/diagnostic device that requires expert-established ground truth for a test set. The evaluation is based on engineering and material standards and comparison to predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The tests are bench tests against established standards or direct comparisons, not requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is not an AI-enabled diagnostic or assistance tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device does not involve an algorithm. The "standalone" performance here refers to the device's functional characteristics in isolation, which were assessed through the bench tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this type of device is defined by:

• Established Industry Standards: Such as ISO 7864, ISO 9626, ISO 6009, ANSI/AAMI/ISO 11135.
• Performance of Legally Marketed Predicate Devices: The McGhan Tissue Expander Fill System (K870754) and other reference devices served as comparators for technological characteristics, materials, and functional performance.

8. The sample size for the training set:
Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:
Not applicable. There is no training set for this type of device.

Summary of the Study:

The document describes a series of non-clinical bench tests rather than a clinical study. These tests were performed to demonstrate that the Unger Quad Injector is substantially equivalent to legally marketed predicate devices, primarily the McGhan Tissue Expander Fill System (K870754).

The specific non-clinical tests conducted include:

• Pre-clinical Investigational Evaluation of Tissue Expander Inter-operative Filling Device
• Quad Injector Flow Rate Comparison
• Unger Quad Injector Bioburden Test
• Unger Quad Injector Endotoxin Test
• Unger Quad Injector Bioburden Validation Test
• Shelf Life / Expiration Dating – Aging Testing
• ISO 7864 Hub Needle Bond Strength
• ISO 7864 and ISO 9626 Conformance

Purpose of the Studies: The main purpose was to verify the equivalence of the Unger Quad Injector's performance, safety, and specifications with the predicate devices, and to ensure conformance with relevant ISO standards.

Conclusion from the Studies: The data from these tests "supports a finding of substantial equivalence because the data demonstrates that the Unger Quad Injector is safely and effectively indicated for use as the 'needle infusion set' component... Testing results demonstrate the filling, sealing capability and leakage prevention as compared to lawfully marketed predicate devices. Performance testing results also demonstrate safety and efficacy in terms of biocompatibility, sterilization, shelf life, and general device performance."

No clinical tests were conducted. The device's safety and effectiveness were established through comparison of its technological characteristics and performance in bench tests to those of existing, legally marketed devices.

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